A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003089

Enrollment

1500

Registered

2018-08-14

Start date

2014-10-16

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Fractional Flow Reserve guided percutaneous coronary intervention vs. coronary artery bypass graft surgery (CABG) for Multivessel Evaluation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 21 years with angina and/or evidence of myocardial ischemia 2. Three vessel CAD, defined as = 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have =50% stenosis 3. Willing and able to provide informed, written consent

Exclusion criteria

Exclusion criteria: 1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization) 2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support 3. Recent STEMI (<5 days prior to randomization) 4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising 5. Known left ventricular ejection fraction <30% 6. Life expectancy < 2 years 7. Requiring renal replacement therapy 8. Undergoing evaluation for organ transplantation 9. Participation or planned participation in another clinical trial, except for observational registries 10. Pregnancy 11. Inability to take dual antiplatelet therapy for six months 12. Previous CABG 13. Left main disease requiring revascularization 14. Extremely calcified or tortuous vessels precluding FFR measurement 15. Any target lesion with in-stent drug-eluting stent restenosis

Design outcomes

Primary

Measure	Time frame
Death, Myocardial infarction, stroke and any repeat revascularization (MACCE)	—

Secondary

Measure	Time frame
Death, Myocardial infarction, and stroke;Death, Myocardial infarction, stroke and any repeat revascularization (MACCE);Myocardial infarction;Repeat revascularization;Stroke	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-jung Park

University of Ulsan

sjpark@amc.seoul.kr+82-2-3010-4812

Outcome results